IRRIGATION BOTTLE

{0}------------------------------------------------ K973829 # 510(k) Summary Automatic Liquid Packaging Inc. Sterile Water and Saline Bottle for Irrigation FEB 2 3 1998 # Submitter: Automatic Liquid Packaging Inc. 2200 W. Lake Shore Drive Woodstock, IL 60098 # Device Name: - Common Name: Sterile Water and Saline Bottle for Irrigation . - Classification Name: Unclassified ● ### Predicate Device: ALP's Prefilled Saline Solution for Irrigation USP # Description of the Device: Automatic Liquid Packaging, Inc. Sterile Water and Saline Solutions are products that have been used in the medical community for decades. These products have not experienced or been associated with toxic or undesirable effects that relate to the ingredients used in their production. The only ingredient in the two solutions other than water is Sodium Chloride; there are no preservatives or stabilizers. The irrigation bottle is manufactured of 100% virgin low density polyethylene (LDPE) and contains no regrind, color or chemical additives. The two solutions are sterile, aseptically filled, and are hermetically sealed for Single Use Only. ### Intended Use: The intended use of the Sterile Water and Saline Irrigation Bottle is to irrigate: - Nasal suctioning and tracheostomy catheters to lubricate these and aid . in their use - Body cavities ● {1}------------------------------------------------ . . . . . . Image /page/1/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three wing segments, positioned to the right of the text. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle, with "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the left side and "USA" on the top right. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856 Automatic Liquid Packaging, Inc. c/o Mr. Eduardo March Senior Consultant AAC Consultant Group 7475 Wisconsin Avenue, Suite 850 20814 Bethesda, MD FEB 2 3 1998 Re : K973829 Irrigation Bottle Regulatory Class: II (Two) 73 JOH Product Code: Dated: January 21, 1998 Received: January 23, 1998 Dear Mr. March: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. this response to your premarket notification Please note: submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations. {2}------------------------------------------------ This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, Thomas J. Callehan Thomas J. Callahan, Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ Page l of of loss. #### K973829 510(k) Number (if known): #### Sterile Water and Saline Solution Irrigation Bottle Device Name: ### Indications for Use: This solution is indicated for use as a tracheal lavage, nasal irrigation solution or as an irrigation solution for flushing a body cavity. ## (PLEASE DO NOT WRITE BELOW THIS LINE- CONIINUE ON ANOTHER PAGE IF NEEDED) # Concurrence of CDRH, Office of Device Evaluation (ODE) **Prescription Use:** Use: (Per 21 CFR 80.109) ✓ OR Over-the-Counter M. Puac̃ (Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number_